Medicinal Products & Lifecycle

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Written by: Ruslan Kuchumov
Category: Expertise
Hits: 12

Medicinal product registration and lifecycle management are the core of the Pharegis regulatory practice. This section brings together three connected workstreams: EAEU medicinal product registration, registration of active pharmaceutical ingredients in Russia, and post-approval variations.

Core workstreams

EAEU medicinal product registration. Regulatory pathway selection, dossier alignment, authority submission and maintenance of the marketing authorisation.

API registration in Russia. Drug-substance and CMC documentation, submission support and ongoing regulatory compliance.

Variations & lifecycle. Change assessment, classification, dossier preparation and implementation under EAEU and applicable national procedures.

The technical guides below retain the historical URLs already used by search engines and provide the detailed regulatory background for these workstreams.

Technical library

Medicinal Products & Lifecycle

Registration, APIs, dossier harmonisation and lifecycle changes

Medicinal Products & Lifecycle

6 articles
EAEU · Registration

Drug Products Registration in Eurasian Economic Union and CIS

Medicinal product registration support in the EAEU: regulatory pathway, CTD dossier alignment, authority submission, market authorization and lifecycle planning.

 Russia · API / CMC

Registration of Active Pharmaceutical Ingredients (API) in Russia

API registration and CMC regulatory support in Russia, covering drug-substance documentation, manufacturing data, dossier preparation and lifecycle compliance.

 Russia / EAEU · Variations

Registration of Drug Dossier Variations in Russia and EAEU

Regulatory support for drug dossier variations in Russia and EAEU, covering change assessment, classification, documentation and lifecycle submissions.

 EAEU · Dossier harmonisation

Bringing National Drug Product Registrations into Compliance with Eurasian Economic Union (EAEU) Requirements

Guidance on bringing national medicinal product dossiers into compliance with EAEU requirements, including dossier conversion and regulatory strategy.

 Russia · Registration

Registration of Drug Products in Russia

Practical guidance and regulatory support for medicinal product registration in Russia, including dossier requirements, studies, quality control and authorization.

 Russia · Variations classification

Classification of Variations to Registration Dossiers for Drug Products (National Procedure — Russia)

Classification of changes to Russian national drug registration dossiers, with practical guidance on variation types, documentation and submission strategy.